UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012089 |
|---|---|
| Receipt number | R000014094 |
| Scientific Title | Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study |
| Date of disclosure of the study information | 2013/10/23 |
| Last modified on | 2019/04/28 18:35:36 |
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Basic information
Public title
Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Acronym
Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Scientific Title
Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Scientific Title:Acronym
Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Region
| Japan |
Condition
Condition
MuSK antibody-positive myasthenia gravis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of rituximab as treatment in MuSK antibody-positive myasthenia gravis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assess the clinical state of patients using a Myasthenia gravis foundation of America post-intervention status (MGFA-PIS), Quantitative MG score for Disease Severity (QMG score), and the amounts of waning of repetitive stimulation tests.
A patient is considered to have responded if they have attained an MGFA-PIS of improved, Minimal Manifestations, Pharmacologic Remission or Complete Stable Remission. The effectiveness evaluation is established by the response rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Rituximab at the standard dose of 375 mg/m2 every week for 4 consecutive weeks and then monthly for the next 3 months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) MuSK antigody-positive MG patients who did not attain remission with oral steroid and immunosuppressors, and need hospitalization for plasma pheresis or high-dose intravenous immunoglobulin.
(2) The patients who are given information about this study and decide to undergo the study and express the consent in consent forms.
Key exclusion criteria
(1) Patients who have severe hypersensitivity or anaphylactic reaction to rituximab or mouse-derived products.
(2) Pregnant women or women of possibility of pregnancy.
(3) Lactating women.
(4) Patients of HBs antigen positive or patients who had HBV infection in their past.
(5) Patients of HBs antigen negative and HBc antibody or HBs antibody positive, and detectable HBV-DNA.
(6) Patients who have received any other experimental drug or investigational product within three months before the start of study treatment in the present study.
(7) Patients who are considered inadequate for this study by Principal investigator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terao |
Organization
University of Tokyo
Division name
Department of Neurology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo
TEL
03-3815-5411
yasuo.terao@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Terao |
Organization
University of Tokyo
Division name
Department of Neurology
Zip code
Address
7-3-1 Hongo Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yasuo.terao@gmail.com
Sponsor or person
Institute
Department of Neurology
University of Tokyo, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology
University of Tokyo, Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 25 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 25 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014094
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